Clinical Follow-up to Evaluate the Clinical Usefulness of Gentamicin-coated Titanium Nails in Tibia Fractures

Tibia Fractures Clinical Trial

Official title: Prospective Open Label Post Market Clinical Follow-up to Evaluate the Clinical Usefulness of the Operative Stabilization of Closed and Open Fractures of the Tibia Using Gentamicin - Coated Titanium Nails

Status Completed

Clinical Trial Summary

This post market clinical follow-up is to confirm the clinical usefulness of the Expert Tibial Nail (ETN) PROtect device for operative stabilization in patients with a tibia fracture as measured by the quality of life (EQ5D, SF-12) instruments, disease-specific questionnaires (Iowa Ankle Score, WOMAC) and assessment of (Non-)Device Related Adverse Events or complications.

Clinical Trial Description

n/a

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fractures, Bone
• Tibia Fractures
• Tibial Fractures

• NCT number: NCT01282294
• Study type: Observational
• Source: Synthes GmbH
• Status: Completed
• Phase: N/A
• Start date: February 2011
• Completion date: December 2013